Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets

NCT ID: NCT02400957

Last Updated: 2015-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Detailed Description

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Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.

Conditions

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Tooth Demineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Silver nanoparticles

Half of the mouth was applied silver nanoparticles. Allocation was randomized.

Group Type EXPERIMENTAL

Silver nanoparticles

Intervention Type OTHER

Half of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Placebo

Half of the mouth was applied placebo. Allocation was randomized.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Half of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Interventions

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Silver nanoparticles

Half of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Intervention Type OTHER

Placebo

Half of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Intervention Type OTHER

Other Intervention Names

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Primer-bond

Eligibility Criteria

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Inclusion Criteria

* Patients candidates for orthodontic treatment.

Exclusion Criteria

* Patients with O.D 11 and / or 21 absent.

* Patients who present dentures of any kind in OD 11 and 21.
* Patients presenting endodontic OD 11 and 21.
* Patients presenting data gingivitis day cementing brackets.
Minimum Eligible Age

10 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma de San Luis Potosí

OTHER

Sponsor Role lead

Responsible Party

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Gabriela Moreno-Meraz

MsC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauricio Pierdant, Profesor

Role: STUDY_DIRECTOR

Universidad Autonoma San Luis Potosi

Locations

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Gabriela Moreno Meraz

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Countries

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Mexico

References

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Hernandez-Sierra JF, Galicia-Cruz O, Angelica SA, Ruiz F, Pierdant-Perez M, Pozos-Guillen AJ. In vitro cytotoxicity of silver nanoparticles on human periodontal fibroblasts. J Clin Pediatr Dent. 2011 Fall;36(1):37-41. doi: 10.17796/jcpd.36.1.d677647166398886.

Reference Type RESULT
PMID: 22900442 (View on PubMed)

Other Identifiers

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CEI-FE-023-013

Identifier Type: -

Identifier Source: org_study_id

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